Status:
COMPLETED
Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Lead Sponsor:
Lung Biotechnology PBC
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.
Detailed Description
Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extension.Each patient will return to the clinic following enrollment in the study ...
Eligibility Criteria
Inclusion
- Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS MR PAH 203 are eligible for this study.
- Women of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal.
Exclusion
- Patients who discontinued study drug during the previous study (BPS MR PAH 203) for any reason (e.g. treatment related adverse events) are not eligible for entry into this study.
- Patients who are pregnant or lactating are excluded from participation in the open-label extension.
Key Trial Info
Start Date :
November 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00990314
Start Date
November 30 2009
End Date
November 30 2013
Last Update
September 16 2019
Active Locations (17)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
2
Midwest Heart Foundation - Advocate Medical Group
Oakbrook Terrace, Illinois, United States, 60181
3
Beth Israel Medical Center
New York, New York, United States, 10003
4
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461